Elite Pharmaceuticals Inc (ELTP)

[Hike]

Perhaps they don't need to.


http://www.fda.gov/downloads/Drugs/.../Guidances/ucm078749.pdf


1. Extrapolation from Existing Studies
In certain cases, effectiveness of an approved drug product for a new indication, or effectiveness of a new product, may be adequately demonstrated without additional adequate and well-controlled clinical efficacy trials. Ordinarily, this will be because other types of data provide a way to apply the known effectiveness to a new population or a different dose, regimen or dosage form. The following are examples of situations in which effectiveness might be extrapolated from efficacy
data for another claim or product.

b. Bioequivalence
The effectiveness of alternative formulations and new dosage strengths may be assessed on the basis of evidence of bioequivalence.

c. Modified-release dosage forms
In some cases, modified release dosage forms may be approved on the
basis of pharmacokinetic data linking the new dosage form to a previously studied immediate-release dosage form. Because the pharmacokinetic patterns of modified-release and immediate-release dosage forms are not identical, it is generally important to have some understanding of the relationship of blood concentration to response, including an understanding of the time course of that relationship, to extrapolate the immediate-release data to the modified-release dosage form.

d. Different doses, regimens, or dosage forms
Dose-response relationships are generally continuous such that information about the effectiveness of one dose, dosage regimen, or dosage form is relevant to the effectiveness of other doses, regimens, or dosage forms.

Where blood levels and exposure are not very different, it may be possible to conclude that a new dose, regimen, or dosage form is effective on the basis of pharmacokinetic data alone. Even if blood levels are quite different, if there is a well-understood relationship between blood concentration and response, including an understanding of the time course of that relationship, it may be possible to conclude that a new dose, regimen, or dosage form is effective on the basis of pharmacokinetic data without an additional clinical efficacy trial. In this situation, pharmacokinetic data, together with the well-defined
pharmacokinetic/pharmacodynamic (PK/PD) relationship, are used to
translate the controlled trial results from one dose, regimen, or dosage
form to a new dose, regimen, or dosage form (See also section II.C.2.a).